Trial Outcomes & Findings for Human Versus Analogue Insulin for Youth With Type 1 Diabetes in Low-Resource Settings (NCT NCT05614089)
NCT ID: NCT05614089
Last Updated: 2025-09-10
Results Overview
% 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.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
400 participants
Primary outcome timeframe
6 and 12 months after randomization
Results posted on
2025-09-10
Participant Flow
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
Participant milestones
| Measure |
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
|
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
|
|---|---|---|
|
Overall Study
STARTED
|
199
|
201
|
|
Overall Study
Clinic Visit 2 (6-months)
|
196
|
199
|
|
Overall Study
Home Visit 2 (6.5-months)
|
196
|
199
|
|
Overall Study
Home Visit 3 (7-months)
|
196
|
199
|
|
Overall Study
COMPLETED
|
188
|
197
|
|
Overall Study
NOT COMPLETED
|
11
|
4
|
Reasons for withdrawal
| Measure |
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
|
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
|
|---|---|---|
|
Overall Study
Pregnancy
|
5
|
2
|
|
Overall Study
Lost to Follow-up
|
5
|
1
|
|
Overall Study
Death
|
0
|
1
|
|
Overall Study
Adverse Event
|
1
|
0
|
Baseline Characteristics
Twenty-three (23) and 26 participants, respectively, had results below the limit, and lab not done in 3 participants in the glargine group.
Baseline characteristics by cohort
| Measure |
Glargine
n=199 Participants
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
|
NPH or Premixed 70/30 (Human Insulin)
n=201 Participants
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
|
Total
n=400 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
17.1 years
STANDARD_DEVIATION 5.2 • n=199 Participants
|
16.6 years
STANDARD_DEVIATION 5.0 • n=201 Participants
|
16.8 years
STANDARD_DEVIATION 5.1 • n=400 Participants
|
|
Age, Customized
Age, categorical · 7 -<10 years
|
26 Participants
n=199 Participants
|
24 Participants
n=201 Participants
|
50 Participants
n=400 Participants
|
|
Age, Customized
Age, categorical · 10 -<18 years
|
84 Participants
n=199 Participants
|
88 Participants
n=201 Participants
|
172 Participants
n=400 Participants
|
|
Age, Customized
Age, categorical · 18 - <26 years
|
89 Participants
n=199 Participants
|
89 Participants
n=201 Participants
|
178 Participants
n=400 Participants
|
|
Sex: Female, Male
Female
|
107 Participants
n=199 Participants
|
115 Participants
n=201 Participants
|
222 Participants
n=400 Participants
|
|
Sex: Female, Male
Male
|
92 Participants
n=199 Participants
|
86 Participants
n=201 Participants
|
178 Participants
n=400 Participants
|
|
Race/Ethnicity, Customized
Ethnicity/Tribe · Bengali
|
124 Participants
n=199 Participants
|
126 Participants
n=201 Participants
|
250 Participants
n=400 Participants
|
|
Race/Ethnicity, Customized
Ethnicity/Tribe · Sukuma
|
41 Participants
n=199 Participants
|
47 Participants
n=201 Participants
|
88 Participants
n=400 Participants
|
|
Race/Ethnicity, Customized
Ethnicity/Tribe · Kurya
|
4 Participants
n=199 Participants
|
4 Participants
n=201 Participants
|
8 Participants
n=400 Participants
|
|
Race/Ethnicity, Customized
Ethnicity/Tribe · Haya
|
2 Participants
n=199 Participants
|
4 Participants
n=201 Participants
|
6 Participants
n=400 Participants
|
|
Race/Ethnicity, Customized
Ethnicity/Tribe · Other
|
28 Participants
n=199 Participants
|
20 Participants
n=201 Participants
|
48 Participants
n=400 Participants
|
|
Region of Enrollment
Bangladesh
|
124 participants
n=199 Participants
|
126 participants
n=201 Participants
|
250 participants
n=400 Participants
|
|
Region of Enrollment
Tanzania
|
75 participants
n=199 Participants
|
75 participants
n=201 Participants
|
150 participants
n=400 Participants
|
|
BMI
|
20.3 (kg/m^2)
STANDARD_DEVIATION 4.0 • n=199 Participants
|
19.8 (kg/m^2)
STANDARD_DEVIATION 3.7 • n=201 Participants
|
20.0 (kg/m^2)
STANDARD_DEVIATION 3.9 • n=400 Participants
|
|
Education of Participant
University
|
14 Participants
n=199 Participants
|
11 Participants
n=201 Participants
|
25 Participants
n=400 Participants
|
|
Education of Participant
College/Diploma
|
44 Participants
n=199 Participants
|
54 Participants
n=201 Participants
|
98 Participants
n=400 Participants
|
|
Education of Participant
Secondary School/Education
|
76 Participants
n=199 Participants
|
67 Participants
n=201 Participants
|
143 Participants
n=400 Participants
|
|
Education of Participant
Primary School/Education
|
64 Participants
n=199 Participants
|
66 Participants
n=201 Participants
|
130 Participants
n=400 Participants
|
|
Education of Participant
No Education
|
1 Participants
n=199 Participants
|
3 Participants
n=201 Participants
|
4 Participants
n=400 Participants
|
|
Education of Parent
University
|
23 Participants
n=199 Participants
|
26 Participants
n=201 Participants
|
49 Participants
n=400 Participants
|
|
Education of Parent
College/Diploma
|
26 Participants
n=199 Participants
|
36 Participants
n=201 Participants
|
62 Participants
n=400 Participants
|
|
Education of Parent
Secondary School/Education
|
93 Participants
n=199 Participants
|
77 Participants
n=201 Participants
|
170 Participants
n=400 Participants
|
|
Education of Parent
Primary School/Education
|
47 Participants
n=199 Participants
|
46 Participants
n=201 Participants
|
93 Participants
n=400 Participants
|
|
Education of Parent
No Education
|
10 Participants
n=199 Participants
|
14 Participants
n=201 Participants
|
24 Participants
n=400 Participants
|
|
Education of Parent
Don't know
|
0 Participants
n=199 Participants
|
2 Participants
n=201 Participants
|
2 Participants
n=400 Participants
|
|
# of Adults Living with
|
3.1 number of people
STANDARD_DEVIATION 1.8 • n=199 Participants
|
2.8 number of people
STANDARD_DEVIATION 1.3 • n=201 Participants
|
2.9 number of people
STANDARD_DEVIATION 1.6 • n=400 Participants
|
|
Socioeconomic Status
Poor
|
97 Participants
n=199 Participants
|
96 Participants
n=201 Participants
|
193 Participants
n=400 Participants
|
|
Socioeconomic Status
Lower middle
|
33 Participants
n=199 Participants
|
29 Participants
n=201 Participants
|
62 Participants
n=400 Participants
|
|
Socioeconomic Status
Middle
|
60 Participants
n=199 Participants
|
63 Participants
n=201 Participants
|
123 Participants
n=400 Participants
|
|
Socioeconomic Status
Upper middle
|
6 Participants
n=199 Participants
|
12 Participants
n=201 Participants
|
18 Participants
n=400 Participants
|
|
Socioeconomic Status
Rice farmer
|
1 Participants
n=199 Participants
|
0 Participants
n=201 Participants
|
1 Participants
n=400 Participants
|
|
Socioeconomic Status
Well off/Rich
|
2 Participants
n=199 Participants
|
1 Participants
n=201 Participants
|
3 Participants
n=400 Participants
|
|
Duration of Type 1 Diabetes
|
5.9 years
STANDARD_DEVIATION 4.2 • n=199 Participants
|
5.9 years
STANDARD_DEVIATION 3.8 • n=201 Participants
|
5.9 years
STANDARD_DEVIATION 4.0 • n=400 Participants
|
|
Type of Insulin Regimen
NPH + Regular with meals
|
196 Participants
n=199 Participants
|
196 Participants
n=201 Participants
|
392 Participants
n=400 Participants
|
|
Type of Insulin Regimen
Premixed 70/30 alone
|
3 Participants
n=199 Participants
|
3 Participants
n=201 Participants
|
6 Participants
n=400 Participants
|
|
Type of Insulin Regimen
Premixed 70/30 + Regular with meals
|
0 Participants
n=199 Participants
|
2 Participants
n=201 Participants
|
2 Participants
n=400 Participants
|
|
Total Number of Units of Insulin per Day/Weight
|
1.0 insulin units/kg per day
STANDARD_DEVIATION 0.4 • n=199 Participants
|
1.1 insulin units/kg per day
STANDARD_DEVIATION 0.4 • n=201 Participants
|
1.0 insulin units/kg per day
STANDARD_DEVIATION 0.4 • n=400 Participants
|
|
HbA1c
|
9.7 percent
STANDARD_DEVIATION 2.8 • n=199 Participants
|
9.9 percent
STANDARD_DEVIATION 2.8 • n=201 Participants
|
9.8 percent
STANDARD_DEVIATION 2.8 • n=400 Participants
|
|
c-peptide
|
0.25 ng/mL
STANDARD_DEVIATION 0.31 • n=173 Participants • Twenty-three (23) and 26 participants, respectively, had results below the limit, and lab not done in 3 participants in the glargine group.
|
0.25 ng/mL
STANDARD_DEVIATION 0.34 • n=175 Participants • Twenty-three (23) and 26 participants, respectively, had results below the limit, and lab not done in 3 participants in the glargine group.
|
0.25 ng/mL
STANDARD_DEVIATION 0.32 • n=348 Participants • Twenty-three (23) and 26 participants, respectively, had results below the limit, and lab not done in 3 participants in the glargine group.
|
|
History of DKA (diabetic ketoacidosis)
Yes
|
53 Participants
n=199 Participants
|
61 Participants
n=201 Participants
|
114 Participants
n=400 Participants
|
|
History of DKA (diabetic ketoacidosis)
No
|
146 Participants
n=199 Participants
|
139 Participants
n=201 Participants
|
285 Participants
n=400 Participants
|
|
History of DKA (diabetic ketoacidosis)
Don't know
|
0 Participants
n=199 Participants
|
1 Participants
n=201 Participants
|
1 Participants
n=400 Participants
|
|
Number of Severe Hypoglycemic Events
|
0.9 number of events
STANDARD_DEVIATION 1.9 • n=198 Participants • One participant in each arm did not know the number of severe hypoglycemic events they had in past 12 months
|
0.8 number of events
STANDARD_DEVIATION 1.7 • n=200 Participants • One participant in each arm did not know the number of severe hypoglycemic events they had in past 12 months
|
0.9 number of events
STANDARD_DEVIATION 1.8 • n=398 Participants • One participant in each arm did not know the number of severe hypoglycemic events they had in past 12 months
|
|
Number of Symptomatic Hypoglycemic Events
|
1.9 number of events
STANDARD_DEVIATION 2.4 • n=188 Participants • Eleven (11) and 7 participants, respectively, did not know the number of symptomatic hypoglycemic events they had in past 30 days
|
2.0 number of events
STANDARD_DEVIATION 2.6 • n=194 Participants • Eleven (11) and 7 participants, respectively, did not know the number of symptomatic hypoglycemic events they had in past 30 days
|
1.9 number of events
STANDARD_DEVIATION 2.5 • n=382 Participants • Eleven (11) and 7 participants, respectively, did not know the number of symptomatic hypoglycemic events they had in past 30 days
|
|
Number of Asymptomatic Hypoglycemic Events
|
1.0 number of events
STANDARD_DEVIATION 2.4 • n=178 Participants • Twenty-one (21) and 7 participants, respectively, did not know the number of asymptomatic hypoglycemic events they had in past 30 days
|
1.1 number of events
STANDARD_DEVIATION 1.9 • n=194 Participants • Twenty-one (21) and 7 participants, respectively, did not know the number of asymptomatic hypoglycemic events they had in past 30 days
|
1.0 number of events
STANDARD_DEVIATION 2.1 • n=372 Participants • Twenty-one (21) and 7 participants, respectively, did not know the number of asymptomatic hypoglycemic events they had in past 30 days
|
|
Retinopathy
|
8 Participants
n=199 Participants
|
6 Participants
n=201 Participants
|
14 Participants
n=400 Participants
|
|
Nephropathy
|
2 Participants
n=199 Participants
|
3 Participants
n=201 Participants
|
5 Participants
n=400 Participants
|
|
Diabetic Foot Disease
|
2 Participants
n=199 Participants
|
0 Participants
n=201 Participants
|
2 Participants
n=400 Participants
|
|
Amputation
|
0 Participants
n=199 Participants
|
0 Participants
n=201 Participants
|
0 Participants
n=400 Participants
|
|
Neuropathy
|
3 Participants
n=199 Participants
|
1 Participants
n=201 Participants
|
4 Participants
n=400 Participants
|
|
Percent Time in Serious Hypoglycemia
|
3.7 percentage of time
STANDARD_DEVIATION 5.0 • n=199 Participants
|
3.7 percentage of time
STANDARD_DEVIATION 5.6 • n=201 Participants
|
3.7 percentage of time
STANDARD_DEVIATION 5.3 • n=400 Participants
|
|
Percent Time in Range
|
38.9 percentage of time
STANDARD_DEVIATION 20.9 • n=199 Participants
|
35.0 percentage of time
STANDARD_DEVIATION 19.3 • n=201 Participants
|
36.9 percentage of time
STANDARD_DEVIATION 20.1 • n=400 Participants
|
|
Percent Time in Hypoglycemia
|
10.9 percentage of time
STANDARD_DEVIATION 10.2 • n=199 Participants
|
10.7 percentage of time
STANDARD_DEVIATION 11.2 • n=201 Participants
|
10.8 percentage of time
STANDARD_DEVIATION 10.7 • n=400 Participants
|
|
Percent Time Above Range
|
50.2 percentage of time
STANDARD_DEVIATION 26.7 • n=199 Participants
|
54.3 percentage of time
STANDARD_DEVIATION 26.6 • n=201 Participants
|
52.3 percentage of time
STANDARD_DEVIATION 26.7 • n=400 Participants
|
|
Nocturnal Hypoglycemic Events
|
3.6 number of events
STANDARD_DEVIATION 3.4 • n=196 Participants • For 3 participants in each arm, the CGM only had 1 active day and did not have any data during the nocturnal hours
|
3.4 number of events
STANDARD_DEVIATION 3.2 • n=198 Participants • For 3 participants in each arm, the CGM only had 1 active day and did not have any data during the nocturnal hours
|
3.5 number of events
STANDARD_DEVIATION 3.3 • n=394 Participants • For 3 participants in each arm, the CGM only had 1 active day and did not have any data during the nocturnal hours
|
|
Pediatric Quality of Life Inventory 3.2 Diabetes Module (PedsQL 3.2 DM) Diabetes Symptoms Score
|
68.1 score on a scale
STANDARD_DEVIATION 14.7 • n=199 Participants
|
69.3 score on a scale
STANDARD_DEVIATION 14.0 • n=201 Participants
|
68.7 score on a scale
STANDARD_DEVIATION 14.4 • n=400 Participants
|
|
Pediatric Quality of Life Inventory 3.2 Diabetes Module (PedsQL 3.2 DM) Diabetes Management Score
|
80.0 score on a scale
STANDARD_DEVIATION 14.3 • n=199 Participants
|
81.5 score on a scale
STANDARD_DEVIATION 13.8 • n=201 Participants
|
80.7 score on a scale
STANDARD_DEVIATION 14.0 • n=400 Participants
|
|
ITSQ Total
|
75.0 score on a scale
STANDARD_DEVIATION 14.4 • n=199 Participants
|
75.6 score on a scale
STANDARD_DEVIATION 14.4 • n=201 Participants
|
75.3 score on a scale
STANDARD_DEVIATION 14.4 • n=400 Participants
|
PRIMARY outcome
Timeframe: 6 and 12 months after randomizationPopulation: Randomized participants still on study with available CGM data at each time point
% 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.
Outcome measures
| Measure |
Glargine
n=195 Participants
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
|
NPH or Premixed 70/30 (Human Insulin)
n=197 Participants
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
|
|---|---|---|
|
Time-in-serious Hypoglycemia
6-month
|
3.6 percentage of time
Standard Deviation 5.6
|
3.4 percentage of time
Standard Deviation 4.3
|
|
Time-in-serious Hypoglycemia
12-month
|
2.4 percentage of time
Standard Deviation 3.5
|
3.8 percentage of time
Standard Deviation 5.5
|
PRIMARY outcome
Timeframe: 6 and 12 months after randomizationPopulation: Randomized participants still on study with available CGM data at each time point
% 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.
Outcome measures
| Measure |
Glargine
n=195 Participants
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
|
NPH or Premixed 70/30 (Human Insulin)
n=197 Participants
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
|
|---|---|---|
|
Time-in-range (TIR)
6-month
|
40.5 percentage of time
Standard Deviation 18.4
|
38.1 percentage of time
Standard Deviation 18.1
|
|
Time-in-range (TIR)
12-month
|
38.5 percentage of time
Standard Deviation 20.1
|
37.7 percentage of time
Standard Deviation 19.7
|
SECONDARY outcome
Timeframe: 6 and 12 months after randomizationPopulation: Randomized participants still on study with available CGM data at each time point
% 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.
Outcome measures
| Measure |
Glargine
n=195 Participants
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
|
NPH or Premixed 70/30 (Human Insulin)
n=197 Participants
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
|
|---|---|---|
|
Time-in-hypoglycemia
6-month
|
10.8 percentage of time
Standard Deviation 9.5
|
10.2 percentage of time
Standard Deviation 8.5
|
|
Time-in-hypoglycemia
12-month
|
9.4 percentage of time
Standard Deviation 10.4
|
11.2 percentage of time
Standard Deviation 10.8
|
SECONDARY outcome
Timeframe: 6 and 12 months after randomizationPopulation: Randomized participants still on study with available CGM data at each time point
% 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.
Outcome measures
| Measure |
Glargine
n=195 Participants
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
|
NPH or Premixed 70/30 (Human Insulin)
n=197 Participants
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
|
|---|---|---|
|
Time-above-range
6-month
|
48.7 percentage of time
Standard Deviation 22.7
|
51.8 percentage of time
Standard Deviation 23.4
|
|
Time-above-range
12-month
|
52.1 percentage of time
Standard Deviation 24.9
|
51.1 percentage of time
Standard Deviation 26.0
|
SECONDARY outcome
Timeframe: 6 and 12 months after randomizationPopulation: Randomized participants still on study with available CGM data during nocturnal hours at each time point
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.
Outcome measures
| Measure |
Glargine
n=195 Participants
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
|
NPH or Premixed 70/30 (Human Insulin)
n=196 Participants
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
|
|---|---|---|
|
Nocturnal Hypoglycemic Events
6-month
|
3.5 number of events
Standard Deviation 2.6
|
3.6 number of events
Standard Deviation 2.7
|
|
Nocturnal Hypoglycemic Events
12-month
|
3.2 number of events
Standard Deviation 2.7
|
4.2 number of events
Standard Deviation 3.5
|
SECONDARY outcome
Timeframe: baseline, 3, 6, 9 and 12 months after randomizationPopulation: Randomized participants still on study with available HbA1c data at each time point
Mean HbA1c lab result reported as percent, which is typically how it is reported.
Outcome measures
| Measure |
Glargine
n=199 Participants
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
|
NPH or Premixed 70/30 (Human Insulin)
n=201 Participants
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
|
|---|---|---|
|
Glycemic Control (HbA1c)
Baseline
|
9.7 percent
Standard Deviation 2.8
|
9.9 percent
Standard Deviation 2.8
|
|
Glycemic Control (HbA1c)
3-month
|
9.3 percent
Standard Deviation 2.5
|
9.4 percent
Standard Deviation 2.5
|
|
Glycemic Control (HbA1c)
6-month
|
9.4 percent
Standard Deviation 2.3
|
9.5 percent
Standard Deviation 2.4
|
|
Glycemic Control (HbA1c)
9-month
|
9.5 percent
Standard Deviation 2.1
|
9.4 percent
Standard Deviation 2.2
|
|
Glycemic Control (HbA1c)
12-month
|
9.4 percent
Standard Deviation 2.3
|
9.4 percent
Standard Deviation 2.5
|
SECONDARY outcome
Timeframe: 6 and 12 months after randomizationPopulation: Randomized participants who knew whether or not they had an event at least one of the time points post-baseline/run-in phase.
Severe hypoglycemic events (requiring assistance of another person to correct) reported by participant per 1000 person-years
Outcome measures
| Measure |
Glargine
n=197 Participants
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
|
NPH or Premixed 70/30 (Human Insulin)
n=200 Participants
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
|
|---|---|---|
|
Rate of Severe Hypoglycemic Events
6-month
|
0 events per 1000 person years
Interval 0.0 to 6.83
|
3.11 events per 1000 person years
Interval 0.0 to 8.54
|
|
Rate of Severe Hypoglycemic Events
12-month
|
1.33 events per 1000 person years
Interval 0.0 to 4.2
|
1.41 events per 1000 person years
Interval 0.0 to 4.29
|
SECONDARY outcome
Timeframe: 6 and 12 months after randomizationPopulation: Randomized participants who knew whether or not they had an event at least one of the time points post-baseline/run-in phase.
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
Outcome measures
| Measure |
Glargine
n=197 Participants
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
|
NPH or Premixed 70/30 (Human Insulin)
n=200 Participants
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
|
|---|---|---|
|
Rate of Diabetic Ketoacidosis (DKA)
6-month
|
0 events per 1000 person years
Interval 0.0 to 0.0
|
0 events per 1000 person years
Interval 0.0 to 0.0
|
|
Rate of Diabetic Ketoacidosis (DKA)
12-month
|
0 events per 1000 person years
Interval 0.0 to 0.0
|
0 events per 1000 person years
Interval 0.0 to 0.0
|
SECONDARY outcome
Timeframe: Baseline and at 6 and 12 months after randomizationPopulation: Randomized participants still on study with available PedsQL data at each time point
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).
Outcome measures
| Measure |
Glargine
n=199 Participants
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
|
NPH or Premixed 70/30 (Human Insulin)
n=201 Participants
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
|
|---|---|---|
|
Pediatric Quality of Life Inventory 3.2 Diabetes Module (PedsQL 3.2 DM) Diabetes Symptoms Score
Baseline
|
68.1 score on a scale
Standard Deviation 14.7
|
69.3 score on a scale
Standard Deviation 14.0
|
|
Pediatric Quality of Life Inventory 3.2 Diabetes Module (PedsQL 3.2 DM) Diabetes Symptoms Score
6-month
|
74.6 score on a scale
Standard Deviation 14.4
|
75.2 score on a scale
Standard Deviation 14.1
|
|
Pediatric Quality of Life Inventory 3.2 Diabetes Module (PedsQL 3.2 DM) Diabetes Symptoms Score
12-month
|
75.9 score on a scale
Standard Deviation 15.1
|
76.9 score on a scale
Standard Deviation 14.5
|
SECONDARY outcome
Timeframe: Baseline and at 6 and 12 months after randomizationPopulation: Randomized participants still on study with available PedsQL data at each time point
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.
Outcome measures
| Measure |
Glargine
n=199 Participants
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
|
NPH or Premixed 70/30 (Human Insulin)
n=201 Participants
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
|
|---|---|---|
|
Pediatric Quality of Life Inventory 3.2 Diabetes Module (PedsQL 3.2 DM) Diabetes Management Score
Baseline
|
80.0 score on a scale
Standard Deviation 14.3
|
81.5 score on a scale
Standard Deviation 13.8
|
|
Pediatric Quality of Life Inventory 3.2 Diabetes Module (PedsQL 3.2 DM) Diabetes Management Score
6-month
|
85.8 score on a scale
Standard Deviation 11.7
|
85.7 score on a scale
Standard Deviation 11.0
|
|
Pediatric Quality of Life Inventory 3.2 Diabetes Module (PedsQL 3.2 DM) Diabetes Management Score
12-month
|
88.0 score on a scale
Standard Deviation 11.0
|
88.8 score on a scale
Standard Deviation 10.3
|
SECONDARY outcome
Timeframe: Baseline and at 6 and 12 months after randomizationPopulation: Randomized participants still on study with available ITSQ data at each time point
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.
Outcome measures
| Measure |
Glargine
n=199 Participants
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
|
NPH or Premixed 70/30 (Human Insulin)
n=201 Participants
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
|
|---|---|---|
|
Insulin Treatment Satisfaction Questionnaire (ITSQ) Scores
Baseline
|
75.0 score on a scale
Standard Deviation 14.4
|
75.6 score on a scale
Standard Deviation 14.4
|
|
Insulin Treatment Satisfaction Questionnaire (ITSQ) Scores
6-month
|
84.1 score on a scale
Standard Deviation 9.0
|
82.1 score on a scale
Standard Deviation 11.1
|
|
Insulin Treatment Satisfaction Questionnaire (ITSQ) Scores
12-month
|
87.1 score on a scale
Standard Deviation 7.9
|
85.9 score on a scale
Standard Deviation 8.6
|
Adverse Events
Glargine
Serious events: 5 serious events
Other events: 33 other events
Deaths: 0 deaths
NPH or Premixed 70/30 (Human Insulin)
Serious events: 13 serious events
Other events: 33 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Glargine
n=199 participants at risk
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
|
NPH or Premixed 70/30 (Human Insulin)
n=201 participants at risk
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
|
|---|---|---|
|
Metabolism and nutrition disorders
Acidosis
|
1.0%
2/199 • Number of events 2 • 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
|
2.5%
5/201 • Number of events 5 • 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
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
0.00%
0/199 • 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
|
1.5%
3/201 • Number of events 3 • 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
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
0.00%
0/199 • 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
|
1.00%
2/201 • Number of events 2 • 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
|
|
Infections and infestations
Lung infection
|
0.50%
1/199 • Number of events 2 • 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
|
0.00%
0/201 • 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
|
|
Infections and infestations
Encephalitis infection
|
0.50%
1/199 • Number of events 1 • 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
|
0.00%
0/201 • 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
|
|
Infections and infestations
Upper respiratory infection
|
0.00%
0/199 • 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
|
0.50%
1/201 • Number of events 1 • 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
|
|
Infections and infestations
Other
|
0.00%
0/199 • 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
|
0.50%
1/201 • Number of events 1 • 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
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/199 • 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
|
0.50%
1/201 • Number of events 1 • 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
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.50%
1/199 • Number of events 1 • 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
|
0.00%
0/201 • 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
|
|
Injury, poisoning and procedural complications
Other
|
0.00%
0/199 • 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
|
0.50%
1/201 • Number of events 1 • 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
|
Other adverse events
| Measure |
Glargine
n=199 participants at risk
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
|
NPH or Premixed 70/30 (Human Insulin)
n=201 participants at risk
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
|
|---|---|---|
|
Metabolism and nutrition disorders
Hypoglycemia
|
15.6%
31/199 • Number of events 31 • 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
|
10.4%
21/201 • Number of events 24 • 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
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
0.50%
1/199 • Number of events 1 • 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
|
0.50%
1/201 • Number of events 1 • 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
|
|
Endocrine disorders
Other
|
1.0%
2/199 • Number of events 2 • 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
|
5.5%
11/201 • Number of events 12 • 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
|
Additional Information
Dr. Jing Luo, MD, MPH, Associate Professor of Medicine
University of Pittsburgh
Phone: 412-383-3559
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place