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| Name | Class |
|---|---|
| The Leona M. and Harry B. Helmsley Charitable Trust | OTHER |
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The primary objective of this trial is to determine whether insulin glargine reduces the risk of serious hypoglycemia or improves Time in Range at 6 months when compared against standard of care human insulin (e.g. NPH or premixed 70/30) among youth living with type 1 diabetes (T1D) in low resource settings.
Long-acting insulin analogues have become a de-facto standard of care for patients with T1D living in high-income countries. Unfortunately, insulin analogues remain unavailable or unaffordable for much of the global population. In both 2017 and 2019, applications to add long-acting insulin analogues to the WHO's Model List of Essential Medicines (EML) were rejected due to insufficient evidence of superiority and an unfavorable cost-effectiveness profile when compared against older, less expensive, human insulins (e.g., NPH insulin and premixed 70/30 insulin). In 2021, long-acting insulin analogues were added to the EML but the decision remains controversial since the WHO concluded that "magnitude of clinical benefit of long-acting insulin analogues over human insulin for most clinical outcomes was small." Moreover, studies that compare long-acting insulin analogues versus human insulins conducted in high-income settings may not generalize to children and young adults living with T1D in very low-resource settings.
To address this unmet need, Pitt has partnered with Brigham and Women's Hospital, The London School of Hygiene and Tropical Medicine, the Clinton Health Access Initiative and Life For a Child to conduct a randomized controlled trial comparing insulin glargine, a long-acting analogue insulin, against intermediate human insulin among 400 children and young adults living with T1D in a lower resource setting.
Note: In preparation for results submission, we made minor changes to the outcomes sections to reflect what is listed in the protocol.
For Primary Outcomes #1 and #2, and Secondary Outcomes #3,#4, #5, #7, #8: we added 12 months measurements (in addition to the 6 months measurement). We updated Secondary Outcome #9 to specify the PedsQL Diabetes Symptoms Score. We added Secondary Outcome #10 to include the PedsQL Diabetes Management Score. We added Secondary Outcome #11 for ITSQ scores.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Glargine | Experimental | Insulin glargine (long-acting insulin analogue) |
|
| NPH or premixed 70/30 (human insulin) | Active Comparator | NPH or premixed 70/30 (human insulin) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Insulin Glargine | Drug | Formulation: Available as a clear liquid in a glass cartridge (1 cartridge =3ml=300 units). Route: Reusable pen Amount of each dose: varies depending on baseline basal insulin needs Dose escalation scheme: Participants randomly assigned to glargine will start with a dose that is generally equal to 80% of their total basal human insulin dose prior to the switch (per ISPAD guidelines and the switching guide developed by Life for a Child with the guidance of Dr. Ragnar Hanas and two other ISPAD members familiar with less-resourced settings). Frequency of dose: once per day (usually administered before bedtime) Duration of therapy: 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Time-in-serious Hypoglycemia | % time spent less than 54 mg/dl averaged across all daily measures. For 6-month outcome, these data were averaged across two CGM sensors (placed at 6 and 6.5 months). For 12-month outcome, these data were from one CGM sensor placed at 11.5 months. | 6 and 12 months after randomization |
| Time-in-range (TIR) | % time spent between 70 and 180mg/dl inclusive averaged across all daily measures. For 6-month outcome, these data were averaged across two CGM sensors (placed at 6 and 6.5 months). For 12-month outcome, these data were from one CGM sensor placed at 11.5 months. | 6 and 12 months after randomization |
| Measure | Description | Time Frame |
|---|---|---|
| Time-in-hypoglycemia | % time spent less than 70mg/dl averaged across all daily measures. For 6-month outcome, these data were averaged across two CGM sensors (placed at 6 and 6.5 months). For 12-month outcome, these data were from one CGM sensor placed at 11.5 months. | 6 and 12 months after randomization |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jing Luo, MD, MPH | University of Pittsburgh | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| BIRDEM Hospital | Dhaka | Bangladesh | ||||
| Bugando Medical Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42409045 | Derived | Luo J, Kehlenbrink S, Chang CH, Lalama CM, Kirsch J, Ansbro E, Prust ML, Garvin A, Zabeen B, Majaliwa E, Ramaiya K, Kayange N, Foulds A, Flabe AH, Nyarubamba RF, Rollman BL, Ogle GD. Human versus analogue insulin for children and young adults with type 1 diabetes in low-resource settings (HumAn-1): a multicentre, open-label, randomised controlled trial. Lancet Diabetes Endocrinol. 2026 Jul 6:S2213-8587(26)00097-5. doi: 10.1016/S2213-8587(26)00097-5. Online ahead of print. | |
| 39890140 |
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De-identified, summary level data will be shared with other researchers, upon request.
3 years after the completion of the primary endpoint (Start 16 September 2024; End 16 September 2027)
Researchers who provide a methodologically sound proposal, upon request
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17 participants consented and had baseline demographics collected in-person and/or baseline/run-in CGM placed, but withdrew from study before randomization to arm due to the following reasons: No longer interested in participating, Became ineligible
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| ID | Title | Description |
|---|---|---|
| FG000 | Glargine | Insulin glargine (long-acting insulin analogue) Insulin Glargine: Formulation: Available as a clear liquid in a glass cartridge (1 cartridge =3ml=300 units). Route: Reusable pen Amount of each dose: varies depending on baseline basal insulin needs Dose escalation scheme: Participants randomly assigned to glargine will start with a dose that is generally equal to 80% of their total basal human insulin dose prior to the switch (per ISPAD guidelines and the switching guide developed by Life for a Child with the guidance of Dr. Ragnar Hanas and two other ISPAD members familiar with less-resourced settings). Frequency of dose: once per day (usually administered before bedtime) Duration of therapy: 12 months |
| FG001 | NPH or Premixed 70/30 (Human Insulin) | NPH or premixed 70/30 (human insulin) NPH or premixed 70/30 (human insulin): Formulation: Available as a liquid in a glass vial or glass cartridge (10ml=1000IU). Route: Bangladesh = syringes or reusable pens; Tanzania = disposable pens Subcutaneous injection using insulin syringe and needle Amount of each dose: varies depending on baseline basal insulin needs (per usual care or treating clinician) Frequency of dose: once or twice per day (per usual care or treating clinician) Duration of therapy: 12 months |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Glargine | Insulin glargine (long-acting insulin analogue) Insulin Glargine: Formulation: Available as a clear liquid in a glass cartridge (1 cartridge =3ml=300 units). Route: Reusable pen Amount of each dose: varies depending on baseline basal insulin needs Dose escalation scheme: Participants randomly assigned to glargine will start with a dose that is generally equal to 80% of their total basal human insulin dose prior to the switch (per ISPAD guidelines and the switching guide developed by Life for a Child with the guidance of Dr. Ragnar Hanas and two other ISPAD members familiar with less-resourced settings). Frequency of dose: once per day (usually administered before bedtime) Duration of therapy: 12 months |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Time-in-serious Hypoglycemia | % time spent less than 54 mg/dl averaged across all daily measures. For 6-month outcome, these data were averaged across two CGM sensors (placed at 6 and 6.5 months). For 12-month outcome, these data were from one CGM sensor placed at 11.5 months. | Randomized participants still on study with available CGM data at each time point | Posted | Mean | Standard Deviation | percentage of time | 6 and 12 months after randomization |
|
Adverse event were data collected through 12 months
Adverse events were assessed periodically throughout a participant's time on study and entered into a standard questionnaire on an as-needed basis
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Glargine | Insulin glargine (long-acting insulin analogue) Insulin Glargine: Formulation: Available as a clear liquid in a glass cartridge (1 cartridge =3ml=300 units). Route: Reusable pen Amount of each dose: varies depending on baseline basal insulin needs Dose escalation scheme: Participants randomly assigned to glargine will start with a dose that is generally equal to 80% of their total basal human insulin dose prior to the switch (per ISPAD guidelines and the switching guide developed by Life for a Child with the guidance of Dr. Ragnar Hanas and two other ISPAD members familiar with less-resourced settings). Frequency of dose: once per day (usually administered before bedtime) Duration of therapy: 12 months |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Acidosis | Metabolism and nutrition disorders | CTCAE 5.0 | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hypoglycemia | Metabolism and nutrition disorders | CTCAE 5.0 | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Jing Luo, MD, MPH, Associate Professor of Medicine | University of Pittsburgh | 412-383-3559 | luoj@pitt.edu |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 9, 2025 | Jul 14, 2025 | Prot_SAP_008.pdf |
| ICF | No | No | Yes | Informed Consent Form: Informed Consent_ Bangladesh site | Jan 2, 2024 | Feb 2, 2024 | ICF_005.pdf |
| ICF | No | No | Yes | Informed Consent Form: Informed Consent_ Tanzania site | Jan 2, 2024 | Feb 2, 2024 | ICF_006.pdf |
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| ID | Term |
|---|---|
| D003922 | Diabetes Mellitus, Type 1 |
| D007333 | Insulin Resistance |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D000069036 | Insulin Glargine |
| D007328 | Insulin |
| ID | Term |
|---|---|
| D049528 | Insulin, Long-Acting |
| D061385 | Insulins |
| D010187 | Pancreatic Hormones |
| D036361 | Peptide Hormones |
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|
| NPH or premixed 70/30 (human insulin) | Drug | Formulation: Available as a liquid in a glass cartridge (3ml=300IU) or as liquid in a prefilled, disposable pen (3ml=300IU). Route: Bangladesh = reusable pens; Tanzania = disposable pens Amount of each dose: varies depending on baseline basal insulin needs (per usual care or treating clinician) Frequency of dose: once or twice per day (per usual care or treating clinician) Duration of therapy: 12 months |
|
| Time-above-range |
% time spent greater than 180mg/dl averaged across all daily measures. For 6-month outcome, these data were averaged across two CGM sensors (placed at 6 and 6.5 months). For 12-month outcome, these data were from one CGM sensor placed at 11.5 months. |
| 6 and 12 months after randomization |
| Nocturnal Hypoglycemic Events | Number of events defined as ≥15 minutes in duration <70 mg/dL between midnight and 6:00 am; specifically, at least 2 sensor values <70 mg/dL that are ≥15 minutes apart plus no intervening values ≥70 mg/dL For 6-month outcome, these data were averaged across two CGM sensors (placed at 6 and 6.5 months). For 12-month outcome, these data were from one CGM sensor placed at 11.5 months. | 6 and 12 months after randomization |
| Glycemic Control (HbA1c) | Mean HbA1c lab result reported as percent, which is typically how it is reported. | baseline, 3, 6, 9 and 12 months after randomization |
| Rate of Severe Hypoglycemic Events | Severe hypoglycemic events (requiring assistance of another person to correct) reported by participant per 1000 person-years | 6 and 12 months after randomization |
| Rate of Diabetic Ketoacidosis (DKA) | Hospitalization or Emergency Room Visit (serious adverse event) with primary diagnosis of Diabetic Ketoacidosis. This was measured by self-report and confirmed through review of hospital records | 6 and 12 months after randomization |
| Pediatric Quality of Life Inventory 3.2 Diabetes Module (PedsQL 3.2 DM) Diabetes Symptoms Score | Mean PedsQL 3.2 DM Diabetes Symptoms score. PedsQL 3.2 DM Diabetes Symptoms scale is composed of 15 items. All items use the same 5-point Likert response scale, with responses ranging from "never" (0) to "almost always" (4). Items are reverse scored and transformed on a scale ranging from 0 to 100. The score is the sum of all the items over the number of items answered. Higher scores indicate fewer diabetes symptoms and therefore improved diabetes-specific health-related quality of life (D-HRQoL). | Baseline and at 6 and 12 months after randomization |
| Pediatric Quality of Life Inventory 3.2 Diabetes Module (PedsQL 3.2 DM) Diabetes Management Score | Mean PedsQL 3.2 DM Diabetes Management score. PedsQL 3.2 DM Diabetes Management scale is composed of 18 items. All items use the same 5-point Likert response scale, with responses ranging from "never" (0) to "almost always" (4). Items are reverse scored and transformed on a scale ranging from 0 to 100. Higher scores indicate fewer diabetes management problems and therefore improved D-HRQoL. | Baseline and at 6 and 12 months after randomization |
| Insulin Treatment Satisfaction Questionnaire (ITSQ) Scores | The ITSQ is composed of 22 items. A total 22-item score is reported, and the items are also divided into five subscales: Regimen Inconvenience (5 items), Lifestyle Flexibility (3 items), Glycemic Control (3 items), Hypoglycemic Control (5 items), and Insulin Delivery Device Satisfaction (6 items). Items use 7-point Likert scale responses, ranging from 1 (positive, e.g. "No bother at all") to 7 (negative, e.g. "A tremendous bother"), though the specific response labels vary by question. Items were reverse scored and transformed to range from 0 to 100. Higher scores indicate higher treatment satisfaction. | Baseline and at 6 and 12 months after randomization |
| Mwanza |
| Tanzania |
| Sekou-Toure Hospital | Mwanza | Tanzania |
| Derived |
| Foulds A, Josey C, Kehlenbrink S, Rollman BL, Chang CH, Lalama C, Ansbro E, Prust ML, Zabeen B, Ramaiya K, Ogle G, Chae SR, Luo J. Human versus Analogue Insulin for Youth with Type 1 Diabetes in Low-Resource Settings (HumAn-1): protocol for a randomised controlled trial. BMJ Open. 2025 Jan 30;15(1):e092432. doi: 10.1136/bmjopen-2024-092432. |
| Death |
|
| Adverse Event |
|
| BG001 | NPH or Premixed 70/30 (Human Insulin) | NPH or premixed 70/30 (human insulin) NPH or premixed 70/30 (human insulin): Formulation: Available as a liquid in a glass vial or glass cartridge (10ml=1000IU). Route: Bangladesh = syringes or reusable pens; Tanzania = disposable pens Subcutaneous injection using insulin syringe and needle Amount of each dose: varies depending on baseline basal insulin needs (per usual care or treating clinician) Frequency of dose: once or twice per day (per usual care or treating clinician) Duration of therapy: 12 months |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Age, Customized | Count of Participants | Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| BMI | Mean | Standard Deviation | (kg/m^2) |
|
| Education of Participant | Count of Participants | Participants |
|
| Education of Parent | Count of Participants | Participants |
|
| # of Adults Living with | Mean | Standard Deviation | number of people |
|
| Socioeconomic Status | Count of Participants | Participants |
|
| Duration of Type 1 Diabetes | Mean | Standard Deviation | years |
|
| Type of Insulin Regimen | Count of Participants | Participants |
|
| Total Number of Units of Insulin per Day/Weight | Mean | Standard Deviation | insulin units/kg per day |
|
| HbA1c | Mean | Standard Deviation | percent |
|
| c-peptide | Twenty-three (23) and 26 participants, respectively, had results below the limit, and lab not done in 3 participants in the glargine group. | Mean | Standard Deviation | ng/mL |
|
| History of DKA (diabetic ketoacidosis) | Count of Participants | Participants |
|
| Number of Severe Hypoglycemic Events | Severe hypoglycemic events (requiring assistance of another person to correct) in past 12 months reported by participant | One participant in each arm did not know the number of severe hypoglycemic events they had in past 12 months | Mean | Standard Deviation | number of events |
|
| Number of Symptomatic Hypoglycemic Events | Symptomatic hypoglycemic events (e.g. dizziness, confusion) in past 30 days reported by participant | Eleven (11) and 7 participants, respectively, did not know the number of symptomatic hypoglycemic events they had in past 30 days | Mean | Standard Deviation | number of events |
|
| Number of Asymptomatic Hypoglycemic Events | Asymptomatic hypoglycemic events (i.e. blood glucose < 3.9 mmol/L (70mg/dl) without clinical symptoms) in past 30 days reported by participant | Twenty-one (21) and 7 participants, respectively, did not know the number of asymptomatic hypoglycemic events they had in past 30 days | Mean | Standard Deviation | number of events |
|
| Retinopathy | Diabetes comorbidities from medical record | Count of Participants | Participants |
|
| Nephropathy | Diabetes comorbidities from medical record | Count of Participants | Participants |
|
| Diabetic Foot Disease | Diabetes comorbidities from medical record | Count of Participants | Participants |
|
| Amputation | Diabetes comorbidities from medical record | Count of Participants | Participants |
|
| Neuropathy | Diabetes comorbidities from medical record | Count of Participants | Participants |
|
| Percent Time in Serious Hypoglycemia | Percent time in serious hypoglycemia (<54 mg/dl) averaged across all daily measures from CGM placed at baseline and worn during run-in phase | Mean | Standard Deviation | percentage of time |
|
| Percent Time in Range | Percent time in glycemic range (70-180 mg/dL, inclusive) averaged across all daily measures from CGM placed at baseline and worn during run-in phase | Mean | Standard Deviation | percentage of time |
|
| Percent Time in Hypoglycemia | Percent time below glycemic range (<70 mg/dl) averaged across all daily measures from CGM placed at baseline and worn during run-in phase | Mean | Standard Deviation | percentage of time |
|
| Percent Time Above Range | Percent time above glycemic range (>180 mg/dl) averaged across all daily measures from CGM placed at baseline and worn during run-in phase | Mean | Standard Deviation | percentage of time |
|
| Nocturnal Hypoglycemic Events | Events are defined as ≥15 minutes in duration <70 mg/dL between midnight and 6:00 am; specifically, at least 2 sensor values <70 mg/dL (from CGM placed at baseline and worn during run-in phase) that are ≥15 minutes apart plus no intervening values ≥70 mg/dL | For 3 participants in each arm, the CGM only had 1 active day and did not have any data during the nocturnal hours | Mean | Standard Deviation | number of events |
|
| Pediatric Quality of Life Inventory 3.2 Diabetes Module (PedsQL 3.2 DM) Diabetes Symptoms Score | PedsQL 3.2 DM Diabetes Symptoms scale is composed of 15 items. All items use the same 5-point Likert response scale, with responses ranging from "never" (0) to "almost always" (4). Items are reverse scored and transformed on a scale ranging from 0 to 100. The score is the sum of all the items over the number of items answered. Higher scores indicate fewer diabetes symptoms and therefore improved D-HRQoL. | Mean | Standard Deviation | score on a scale |
|
| Pediatric Quality of Life Inventory 3.2 Diabetes Module (PedsQL 3.2 DM) Diabetes Management Score | PedsQL 3.2 DM Diabetes Management scale is composed of 18 items. All items use the same 5-point Likert response scale, with responses ranging from "never" (0) to "almost always" (4). Items are reverse scored and transformed on a scale ranging from 0 to 100. Higher scores indicate fewer diabetes management problems and therefore improved D-HRQoL. | Mean | Standard Deviation | score on a scale |
|
| ITSQ Total | The ITSQ total score is composed of 22 items comprised of five subscales: Regimen Inconvenience (5 items), Lifestyle Flexibility (3 items), Glycemic Control (3 items), Hypoglycemic Control (5 items), and Insulin Delivery Device Satisfaction (6 items). Items use 7-point Likert scale responses, ranging from 1 (positive, e.g. "No bother at all") to 7 (negative, e.g. "A tremendous bother"), though the specific response labels vary by question. Items were reverse scored and transformed to range from 0 to 100. Higher scores indicate higher treatment satisfaction. | Mean | Standard Deviation | score on a scale |
|
| OG001 | NPH or Premixed 70/30 (Human Insulin) | NPH or premixed 70/30 (human insulin) NPH or premixed 70/30 (human insulin): Formulation: Available as a liquid in a glass vial or glass cartridge (10ml=1000IU). Route: Bangladesh = syringes or reusable pens; Tanzania = disposable pens Subcutaneous injection using insulin syringe and needle Amount of each dose: varies depending on baseline basal insulin needs (per usual care or treating clinician) Frequency of dose: once or twice per day (per usual care or treating clinician) Duration of therapy: 12 months |
|
|
|
| Primary | Time-in-range (TIR) | % time spent between 70 and 180mg/dl inclusive averaged across all daily measures. For 6-month outcome, these data were averaged across two CGM sensors (placed at 6 and 6.5 months). For 12-month outcome, these data were from one CGM sensor placed at 11.5 months. | Randomized participants still on study with available CGM data at each time point | Posted | Mean | Standard Deviation | percentage of time | 6 and 12 months after randomization |
|
|
|
|
| Secondary | Time-in-hypoglycemia | % time spent less than 70mg/dl averaged across all daily measures. For 6-month outcome, these data were averaged across two CGM sensors (placed at 6 and 6.5 months). For 12-month outcome, these data were from one CGM sensor placed at 11.5 months. | Randomized participants still on study with available CGM data at each time point | Posted | Mean | Standard Deviation | percentage of time | 6 and 12 months after randomization |
|
|
|
|
| Secondary | Time-above-range | % time spent greater than 180mg/dl averaged across all daily measures. For 6-month outcome, these data were averaged across two CGM sensors (placed at 6 and 6.5 months). For 12-month outcome, these data were from one CGM sensor placed at 11.5 months. | Randomized participants still on study with available CGM data at each time point | Posted | Mean | Standard Deviation | percentage of time | 6 and 12 months after randomization |
|
|
|
|
| Secondary | Nocturnal Hypoglycemic Events | Number of events defined as ≥15 minutes in duration <70 mg/dL between midnight and 6:00 am; specifically, at least 2 sensor values <70 mg/dL that are ≥15 minutes apart plus no intervening values ≥70 mg/dL For 6-month outcome, these data were averaged across two CGM sensors (placed at 6 and 6.5 months). For 12-month outcome, these data were from one CGM sensor placed at 11.5 months. | Randomized participants still on study with available CGM data during nocturnal hours at each time point | Posted | Mean | Standard Deviation | number of events | 6 and 12 months after randomization |
|
|
|
|
| Secondary | Glycemic Control (HbA1c) | Mean HbA1c lab result reported as percent, which is typically how it is reported. | Randomized participants still on study with available HbA1c data at each time point | Posted | Mean | Standard Deviation | percent | baseline, 3, 6, 9 and 12 months after randomization |
|
|
|
|
| Secondary | Rate of Severe Hypoglycemic Events | Severe hypoglycemic events (requiring assistance of another person to correct) reported by participant per 1000 person-years | Randomized participants who knew whether or not they had an event at least one of the time points post-baseline/run-in phase. | Posted | Number | 95% Confidence Interval | events per 1000 person years | 6 and 12 months after randomization |
|
|
|
|
| Secondary | Rate of Diabetic Ketoacidosis (DKA) | Hospitalization or Emergency Room Visit (serious adverse event) with primary diagnosis of Diabetic Ketoacidosis. This was measured by self-report and confirmed through review of hospital records | Randomized participants who knew whether or not they had an event at least one of the time points post-baseline/run-in phase. | Posted | Number | 95% Confidence Interval | events per 1000 person years | 6 and 12 months after randomization |
|
|
|
|
| Secondary | Pediatric Quality of Life Inventory 3.2 Diabetes Module (PedsQL 3.2 DM) Diabetes Symptoms Score | Mean PedsQL 3.2 DM Diabetes Symptoms score. PedsQL 3.2 DM Diabetes Symptoms scale is composed of 15 items. All items use the same 5-point Likert response scale, with responses ranging from "never" (0) to "almost always" (4). Items are reverse scored and transformed on a scale ranging from 0 to 100. The score is the sum of all the items over the number of items answered. Higher scores indicate fewer diabetes symptoms and therefore improved diabetes-specific health-related quality of life (D-HRQoL). | Randomized participants still on study with available PedsQL data at each time point | Posted | Mean | Standard Deviation | score on a scale | Baseline and at 6 and 12 months after randomization |
|
|
|
|
| Secondary | Pediatric Quality of Life Inventory 3.2 Diabetes Module (PedsQL 3.2 DM) Diabetes Management Score | Mean PedsQL 3.2 DM Diabetes Management score. PedsQL 3.2 DM Diabetes Management scale is composed of 18 items. All items use the same 5-point Likert response scale, with responses ranging from "never" (0) to "almost always" (4). Items are reverse scored and transformed on a scale ranging from 0 to 100. Higher scores indicate fewer diabetes management problems and therefore improved D-HRQoL. | Randomized participants still on study with available PedsQL data at each time point | Posted | Mean | Standard Deviation | score on a scale | Baseline and at 6 and 12 months after randomization |
|
|
|
|
| Secondary | Insulin Treatment Satisfaction Questionnaire (ITSQ) Scores | The ITSQ is composed of 22 items. A total 22-item score is reported, and the items are also divided into five subscales: Regimen Inconvenience (5 items), Lifestyle Flexibility (3 items), Glycemic Control (3 items), Hypoglycemic Control (5 items), and Insulin Delivery Device Satisfaction (6 items). Items use 7-point Likert scale responses, ranging from 1 (positive, e.g. "No bother at all") to 7 (negative, e.g. "A tremendous bother"), though the specific response labels vary by question. Items were reverse scored and transformed to range from 0 to 100. Higher scores indicate higher treatment satisfaction. | Randomized participants still on study with available ITSQ data at each time point | Posted | Mean | Standard Deviation | score on a scale | Baseline and at 6 and 12 months after randomization |
|
|
|
|
| 0 |
| 199 |
| 5 |
| 199 |
| 33 |
| 199 |
| EG001 | NPH or Premixed 70/30 (Human Insulin) | NPH or premixed 70/30 (human insulin) NPH or premixed 70/30 (human insulin): Formulation: Available as a liquid in a glass vial or glass cartridge (10ml=1000IU). Route: Bangladesh = syringes or reusable pens; Tanzania = disposable pens Subcutaneous injection using insulin syringe and needle Amount of each dose: varies depending on baseline basal insulin needs (per usual care or treating clinician) Frequency of dose: once or twice per day (per usual care or treating clinician) Duration of therapy: 12 months | 1 | 201 | 13 | 201 | 33 | 201 |
| Hypoglycemia | Metabolism and nutrition disorders | CTCAE 5.0 | Non-systematic Assessment |
|
| Hyperglycemia | Metabolism and nutrition disorders | CTCAE 5.0 | Non-systematic Assessment |
|
| Lung infection | Infections and infestations | CTCAE 5.0 | Non-systematic Assessment |
|
| Encephalitis infection | Infections and infestations | CTCAE 5.0 | Non-systematic Assessment |
|
| Upper respiratory infection | Infections and infestations | CTCAE 5.0 | Non-systematic Assessment |
|
| Other | Infections and infestations | CTCAE 5.0 | Non-systematic Assessment | Severe Malaria |
|
| Diarrhea | Gastrointestinal disorders | CTCAE 5.0 | Non-systematic Assessment |
|
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | CTCAE 5.0 | Non-systematic Assessment |
|
| Other | Injury, poisoning and procedural complications | CTCAE 5.0 | Non-systematic Assessment |
|
| Hyperglycemia | Metabolism and nutrition disorders | CTCAE 5.0 | Non-systematic Assessment |
|
| Other | Endocrine disorders | CTCAE 5.0 | Non-systematic Assessment |
|
Not provided
Not provided
| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D006946 | Hyperinsulinism |
| D006728 |
| Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D011384 | Proinsulin |
| 18 - <26 years |
|
| Kurya |
|
| Haya |
|
| Other |
|
| Secondary School/Education |
|
| Primary School/Education |
|
| No Education |
|
| Secondary School/Education |
|
| Primary School/Education |
|
| No Education |
|
| Don't know |
|
| Middle |
|
| Upper middle |
|
| Rice farmer |
|
| Well off/Rich |
|
| Premixed 70/30 + Regular with meals |
|
| Don't know |
|
| 12-month |
|
|
|
12-month |
| Regression, Linear |
Multivariable generalized linear regression model adjusted for age at screening, study site, and % TIR at baseline |
| 0.64 |
Since this is one of two coprimary outcomes (this outcome and % time in serious hypoglycemia), a win (p<0.025 for benefit) on either outcome will be considered to be a positive trial. |
| Superiority |
| 12-month |
|
|
| Regression, Linear |
Multivariable generalized linear regression model adjusted for age at screening, study site, and % time in hypoglycemia at baseline |
| 0.07 |
| Superiority |
| 12-month |
|
|
| Regression, Linear |
Multivariable generalized linear regression model adjusted for age at screening, study site, and % time above range at baseline |
| 0.21 |
| Superiority |
| 12-month |
|
|
| Regression, Linear |
Multivariable generalized linear regression model adjusted for age at screening, study site, and number of nocturnal events at baseline |
| 0.02 |
| Superiority |
| 3-month |
|
|
| 6-month |
|
|
| 9-month |
|
|
| 12-month |
|
|
| Regression, Linear |
Multivariable generalized linear regression model adjusted for age at screening, study site, and HbA1c at baseline |
| 0.29 |
| Superiority |
| Negative Binomial Regression |
Negative binomial regression model adjusted for age at screening and study site |
| 0.61 |
| Superiority |
| Negative Binomial Regression |
Negative binomial regression model adjusted for age at screening and study site |
| 0.09 |
| Superiority |
| 6-month |
|
|
| 12-month |
|
|
| Regression, Linear |
Multivariable generalized linear regression model adjusted for age at screening, study site, and PedsQL 3.2 DM Diabetes Symptoms score at baseline |
| 0.73 |
| Superiority |
| 6-month |
|
|
| 12-month |
|
|
| Regression, Linear |
Multivariable generalized linear regression model adjusted for age at screening, study site, and PedsQL 3.2 DM Diabetes Management score at baseline |
| 0.44 |
| Superiority |
| 6-month |
|
|
| 12-month |
|
|
| Regression, Linear |
Multivariable generalized linear regression model adjusted for age at screening, study site, and ITSQ at baseline |
| 0.10 |
| Superiority |